Histogenics Completes 50% Enrollment in NeoCart Phase III Trial

By Julie A. Vetalice

Histogenics has enrolled 123 (>50%) of the 245 patients required to complete enrollment in its ongoing NeoCart® Phase III clinical trial.  This trial is being conducted under a Special Protocol Assessment with FDA.

Company leadership attributes its progress to enrollment-enhancing strategies implemented in 2015, as well as changes by FDA in 4Q15 to the Phase III clinical trial inclusion/exclusion criteria. Trial enrollment is expected to complete in 2Q17.

The trial is investigating NeoCart autologous cell therapy vs. microfracture as a first-line approach for the treatment of full thickness adult knee cartilage defects.

Source: Histogenics Corporation

Product Labels: Orthobiologic Soft Tissue Repair

Tags: Trial/Study